Abbott Vascular's Bioresorbable Scaffold Programme, a new paradigm in PCI
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ein for presentation outside of the U.S. and Japan only. Not to be reproduced, distributed or excerpt AP2934106 Rev. A 1 Abbott Vascular's Bioresorbable Scaffold Programme, a new paradigm in PCI Richard J. Rapoza, PhD Divisional Vice President of R&D
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Abbott Vascular's Bioresorbable Scaffold Programme, a new paradigm in PCI. Richard J. Rapoza, PhD Divisional Vice President of R&D. MY CONFLICTS OF INTEREST ARE: Full time employee of Abbott Vascular. The Evolution of PCI Treatment Options. - PowerPoint PPT Presentation
Transcript of Abbott Vascular's Bioresorbable Scaffold Programme, a new paradigm in PCI
Information contained herein for presentation outside of the U.S. and Japan only. Not to be reproduced, distributed or excerpted. AP2934106 Rev. A
1
Abbott Vascular's Bioresorbable Scaffold Programme, a new
paradigm in PCI
Richard J. Rapoza, PhD
Divisional Vice President of R&D
Information contained herein for presentation outside of the U.S. and Japan only. Not to be reproduced, distributed or excerpted. AP2934106 Rev. A
2
MY CONFLICTS OF INTEREST ARE:
Full time employee of Abbott Vascular
Information contained herein for presentation outside of the U.S. and Japan only. Not to be reproduced, distributed or excerpted. AP2934106 Rev. A
3
The Evolution of PCI Treatment OptionsBenefits Detriments TLR
PTCA1970s
• Minimally invasive alternative to CABG• Excellent long-term durability of results for patients who did well through ~6 months
• Acute/sub-acute closure• High restenosis rates due to negative vessel remodeling
30 – 50%
BMS1980s
• Eliminated abrupt and sub-acute closure• Reduced restenosis rates compared to PTCA
• Neointimal hyperplasia resulting in in-stent restenosis
15 – 30%
DES2000s
• Significantly reduced neointimal hyperplasia• Reduced restenosis rates compared to BMS
• Late and very late stent thrombosis• Dependence on long-term DAPT
5 – 10%
Each of these new technologies addressed the shortcomings of the previous technology, but with their introduction arrived new, significant concerns
Information contained herein for presentation outside of the U.S. and Japan only. Not to be reproduced, distributed or excerpted. AP2934106 Rev. A
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A New Therapy?: Vascular Restoration Therapy
Medical Therapy PCI CABG
PTCA Stenting VRT
Devices Used: BDC BMS DES BVS
Information contained herein for presentation outside of the U.S. and Japan only. Not to be reproduced, distributed or excerpted. AP2934106 Rev. A
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Vascular Restoration Therapy (VRT)
Restoration ResorptionRevascularization
Restore vasomotor function
Restore natural vessel structure
Restore flow
BMS & DES only accomplish this
Only possible in the absence of a permanent implant
Vessel is restored to a more natural state, capable of natural vascular function
Information contained herein for presentation outside of the U.S. and Japan only. Not to be reproduced, distributed or excerpted. AP2934106 Rev. A
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1 3 6 24 Mos
Support
Mass Loss
Tie chains
MolecularWeight
12 18
Polylactide Degradation vs Lumen Support
Data on file at Abbott Vascular.
Information contained herein for presentation outside of the U.S. and Japan only. Not to be reproduced, distributed or excerpted. AP2934106 Rev. A
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Model derived from Prabhu S and Hossainy S, J. Biomed. Mater. Res., Pt. A 2007; 80: 732.
Tests were performed by and data are on file at Abbott Vascular.
BVS Resorption in Healthy Porcine Model
1
4
523
1 month
1
6 months
2
1 year
3
18 months
10X Magnification
4
2 years
5
Information contained herein for presentation outside of the U.S. and Japan only. Not to be reproduced, distributed or excerpted. AP2934106 Rev. A
8Photos taken by and on file at Abbott Vascular.
2 years 3 years 4 years
Tests performed by and data on file at Abbott Vascular.
1.5 years
% Mass Remaining
45 0 - 5 0 0
Long Term Biological Response
Information contained herein for presentation outside of the U.S. and Japan only. Not to be reproduced, distributed or excerpted. AP2934106 Rev. A
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0%
10%
20%
30%
40%
50%
60%
70%
80%
90%
100%
-0.5 0 0.5 1 1.5 2
In-Stent Late-Loss (mm)
% P
atie
nts BVS 1.0
BVS 1.1
EES
BMS
■ BVS Cohort A (n = 26) ■ BVS Cohort B1 (n = 42 ITT) ▲ EES (n = 22)* BMS (n = 27)*
ABSORB Cohort B 6-Month QCACumulative Incidence Curve for Late Loss
Adapted from Serruys, PW. PCR 2010
BMS LL = 0.85 ± 0.36 mm
BVS Cohort A LL = 0.44 ± 0.35mm
BVS Cohort B1 LL = 0.19 ± 0.18 mm
EES LL = 0.10 ± 0.23 mm
* SPIRIT-FIRST
ABSORB is a trademarkof the Abbott Group of Companies
Information contained herein for presentation outside of the U.S. and Japan only. Not to be reproduced, distributed or excerpted. AP2934106 Rev. A
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ABSORB Cohort A Clinical Results – Intent to treat
Hierarchical6 Months
(n = 30)
12 Months
(n = 29)*
24 Months
(n = 29)*
36 Months
(n = 29)*
48 Months
(n = 29)*
Ischemia Driven MACE
1 (3.3%)** 1 (3.4%)** 1 (3.4%)** 1 (3.4%)** 1 (3.4%)**
Cardiac Death 0 (0.0%) 0 (0.0%) 0 (0.0%) 0 (0.0%) 0 (0.0%)
MI 1 (3.3%)** 1 (3.4%)** 1 (3.4%)** 1 (3.4%)** 1 (3.4%)**
Q-Wave MI 0 (0.0%) 0 (0.0%) 0 (0.0%) 0 (0.0%) 0 (0.0%)
Non Q-Wave MI 1 (3.3%)** 1 (3.4%)** 1 (3.4%)** 1 (3.4%)** 1 (3.4%)**
Ischemia Driven TLR 0 (0.0%) 0 (0.0%) 0 (0.0%) 0 (0.0%) 0 (0.0%)
by PCI 0 (0.0%) 0 (0.0%) 0 (0.0%) 0 (0.0%) 0 (0.0%)
by CABG 0 (0.0%) 0 (0.0%) 0 (0.0%) 0 (0.0%) 0 (0.0%)
No new MACE between 6 and 48 months
* One patient withdrew consent and missed the 9, 12, 18 month and 2, 3 and 4 year visits
**This patient also underwent a TLR, not qualified as ID-TLR (DS = 42%) followed by post-procedural troponin qualified as NQMI and died from Hodgkin’s disease at 888 days post-procedure
Serruys, PW., AHA 2010.
No thrombosis up to 4 years (all patients off clopidogrel)ABSORB is a trademark of the Abbott Group of Companies
Information contained herein for presentation outside of the U.S. and Japan only. Not to be reproduced, distributed or excerpted. AP2934106 Rev. A
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ABSORB Cohort B Clinical Results - Intent to treat, Group 1
No thrombosis by ARC or Protocol
Non-Hierarchical
Cardiac Death (%)
Myocardial Infarction n (%)Q-wave MINon Q-wave MI
Ischemia Driven TLR n (%)PCICABG
Hierarchical MACE n (%)
Hierarchical TLF n (%)
30 Days 6 MonthsN = 45N = 45
0 0
1 (2.2) 1 (2.2)0 0
1 (2.2) 1 (2.2)
1 (2.2)01 (2.2)0
0 0
1 (2.2) 2 (4.4)
1 (2.2) 2 (4.4)
MACE: cardiac death, MI, ischemia-driven TLRTLF: cardiac death, MI, ischemmia-driven TLR, ischemia-driven TVR
9 MonthsN = 45
0
1 (2.2)0
1 (2.2)
1 (2.2)1 (2.2)
0
2 (4.4)
2 (4.4)
Serruys, PW., TCT 2010
Ormiston, J., TCT 2010ABSORB is a trademark of the Abbott Group of Companies
Information contained herein for presentation outside of the U.S. and Japan only. Not to be reproduced, distributed or excerpted. AP2934106 Rev. A
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ABSORB Cohort B Clinical Results - Intent to treat, Group 1&2
No thrombosis by ARC or Protocol
Non-Hierarchical
Cardiac Death (%)
Myocardial Infarction n (%)Q-wave MINon Q-wave MI
Ischemia Driven TLR n (%)PCICABG
Hierarchical MACE n (%)
Hierarchical TLF n (%)
30 Days 6 MonthsN = 101N = 101
0 0
2 (2.0) 3 (3.0)0 0
2 (2.0) 3 (3.0)
2 (2.0)02 (2.0)0
0 0
2 (2.0) 5 (5.0)
2 (2.0) 5 (5.0)
MACE: cardiac death, MI, ischemia-driven TLRTLF: cardiac death, MI, ischemmia-driven TLR, ischemia-driven TVR
Serruys, PW., AHA 2010.
9 MonthsN = 101
0
3 (3.0)0
3 (3.0)
2 (2.0)2 (2.0)
0
5 (5.0)
5 (5.0)
ABSORB is a trademark of the Abbott Group of Companies
Information contained herein for presentation outside of the U.S. and Japan only. Not to be reproduced, distributed or excerpted. AP2934106 Rev. A
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Baseline 6 mo follow up
BaselineMLA: 7.39 mm2
Follow upMLA: 8.18 mm2
Coverage: 60 μm
ABSORB Cohort B: OCT example
ABSORB is a trademark of the Abbott Group of Companies
Serruys, PW. PCR 2010
Serruys, PW. CCT 2010
